Form Fda 356h - Application To Market A New Or Abbreviated New Drug Or Biologic For Human Use Form
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Form Approved: OMB No. 0910-0338
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Expiration Date: December 31, 2017
Food and Drug Administration
See PRA Statement on page 3.
APPLICATION TO MARKET A NEW OR ABBREVIATED NEW
DRUG OR BIOLOGIC FOR HUMAN USE
1. Date of Submission (mm/dd/yyyy)
(Title 21, Code of Federal Regulations, Parts 314 & 601)
2. Name of Applicant
APPLICANT INFORMATION
3. Telephone Number (Include country code if applicable and area code) 4. Facsimile (FAX) Number (Include country
code if applicable and area code)
5. Applicant Address
Address 1 (Street address, P.O. box, company name c/o)
Email Address
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
State/Province/Region
U.S. License Number if previously issued
Country
ZIP or Postal Code
6. Authorized U.S. Agent (Required for non-U.S. applicants)
Authorized U.S. Agent Name
Telephone Number (Include area code)
Address 1 (Street address, P.O. box, company name c/o)
FAX Number (Include area code)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
State
Email Address
ZIP Code
7. NDA, ANDA, or BLA Application Number
8. Supplement Number (If applicable)
PRODUCT DESCRIPTION
9. Established Name (e.g., proper name, USP/USAN name)
10. Proprietary Name (Trade Name) (If any)
11. Chemical/Biochemical/Blood Product Name (If any)
12. Dosage Form
13. Strengths
14. Route of Administration
15. Proposed Indication for Use
Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Yes
No
Does this product have an FDA
If yes, provide the Orphan
Orphan Designation for this
Designation number for this
Contin.
indication?
indication:
Page for
#15
Yes
No
16.
Application Type
APPLICATION INFORMATION
New Drug Application (NDA)
Biologics License Application (BLA)
(Select one)
Abbreviated New Drug Application (ANDA)
17. If an NDA, identify the type
18. If a BLA, identify the type
505(b)(1)
505(b)(2)
351(a)
351(k)
19. If a 351(k), identify the biological reference product that is the basis for the submission.
Name of Biologic:
Holder of Licensed Application:
20. If an ANDA, or 505(b)(2), identify the listed drug product that is the basis for the submission.
Name of Drug:
Application Number of Relied Upon Product:
Indicate Patent Certification(s):
P1
P2
P3
P4
Section viii - MOU
Statement of no relevant patents
21. Submission (See
Original
Labeling Supplement
CMC Supplement
Efficacy Supplement
Annual Report
instructions)
Product Correspondence
REMS Supplement
Postmarketing Requirements or Commitments
Periodic Safety Report
Other (Specify):
3
FORM FDA 356h (8/15)
Page 1 of
EF
PSC Publishing Services (301) 443-6740
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